The Effectiveness and Safety of Intravesical Gemcitabine Instillation to Prevent Intravesical Recurrence
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Urothelial Carcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 20 years and 84 years
- Gender
- Both males and females
Description
Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Outcome Measures: Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Secondary Outcome Measures: Time to recurrence in intravesical 2000mg/52.6ml gemci...
Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Outcome Measures: Two year recurrence-free survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Secondary Outcome Measures: Time to recurrence in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Overall survival in intravesical 2000mg/52.6ml gemcitabine instillation group and control group. Safety of intravesical 2000mg/52.6ml gemcitabine instillation.
Tracking Information
- NCT #
- NCT03062059
- Collaborators
- Samsung Medical Center
- Asan Medical Center
- Seoul National University Hospital
- Korea University Anam Hospital
- Chong Kun Dang Pharmaceutical Corp.
- Investigators
- Principal Investigator: Seok Ho Kang, M.D. Korea universitiy
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